Capnographic Monitoring of Propofol-sedation During Colonoscopy

Not Applicable

Completed

• Conditions: Hypoxia
• Interventions: Device: Microcap (Oridion, Needham, MA, USA); Device: Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)

• Registration Number: NCT01638793
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-06
• Study Start: 2012-06
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-12
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

• Indication for colonoscopy
• Patient wishing sedation during colonoscopy
• ≥ 18 years of age
• Signed informed consent form

Exclusion Criteria

• Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
• Non-contractually capable persons
• Pregnancy
• Lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capnography	Microcap (Oridion, Needham, MA, USA)	Capnographic respiration monitoring
Pulse-Oxymetry	Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)	pulse-oxymetric respiration monitoring

Primary Outcome Measures

Name	Time	Method
Hypoxia (SO2 <90%)		Study objective is to evaluate if a reduction of hypoxic events (SO2 \<90% for ≥ 15 sec) can be obtained with capnographic monitoring as compared to standard monitoring of respiration with pulse-oxymetry in patients receiving colonoscopy under Propofol-based sedation

Secondary Outcome Measures

Name	Time	Method
Severe Hypoxia (SO2 <85%)		Evaluate events of severe hypoxia (SO2 \< 85%) in group 1 (capnographic monitoring) as compared to group 2 (oxymetric monitoring)
Time to hypoxia		Evaluate the time difference between abnormal ventilation shown on capnography machine and hypoxemia.
Hypoxia in relation to sedation		Compare events of hypoxemia and severe hypoxemia during sedation with propofol only as compared to propofol/ketamin combination sedation.
Vegetative Symptoms		Evaluate vegetative events (hypotension, hypertension, bradycardia, tachycardia, tachypnea, bradypnea) in both groups during the two sedation forms

Trial Locations

Locations (2)

Klinikum der J. W. Goethe-Universität; 🇩🇪 Frankfurt am Main, Germany

Praxisklinik am Staedel; 🇩🇪 Frankfurt am Main, Germany